Optimising recruitment into trials using an internal pilot.

ABSTRACT

BACKGROUND: Recruitment to trials can be difficult. Despite careful planning and research that outlines ways to improve recruitment, many trials do not achieve their target on time and require extensions of funding or time. METHODS: We describe a trial in which an internal pilot with embedded qualitative research was used to improve recruitment processes and inform recruitment projections for the main trial. At the end of the pilot, it was clear that the sample size would not be met on time. Three steps were taken to optimise recruitment (1) adjustments were made to the recruitment process using information from the qualitative work done in the pilot and advice from a patient and public involvement group, (2) additional recruiting sites were included based on site feasibility assessments and (3) a projection equation was used to estimate recruitment at each site and overall trial recruitment. RESULTS: Qualitative work during the pilot phase allowed us to develop strategies to optimise recruitment during the main trial, which were incorporated into patient information packs, the standard operating procedures and training sessions with recruiters. From our experience of feasibility assessments, we developed a checklist of recommended considerations for feasibility assessments. For recruitment projections, we developed a four-stage projection equation that estimates the number of participants recruited using a conversion rate of the number randomised divided by the number screened. CONCLUSIONS: This work provides recommendations for feasibility assessments and an easy-to-use projection tool, which can be applied to other trials to help ensure they reach the required sample size. TRIAL REGISTRATION ISRCTN, ISRCTN92545361 . Registered on 6 September 2016.